Excelya

Clinical Quality Assurance Officer

Excelya

full-time

Posted on:

Location Type: Hybrid

Location: Paris • France

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Tech Stack

Google Cloud Platform

About the role

  • **Main Responsibilities:**
  • - Conduct internal and external audits related to clinical research (GCP, investigator sites, vendors, systems).
  • - Prepare audit plans, perform risk assessments, and document findings in detailed audit reports.
  • - Follow up on corrective and preventive actions (CAPA) and ensure timely and effective implementation.
  • - Support teams during regulatory inspections (EMA, ANSM, FDA or other competent authorities).
  • - Review and contribute to the development of SOPs, quality documents, and clinical processes.
  • - Provide training and quality guidance to operational teams to reinforce compliance and best practices.
  • - Monitor regulatory and industry updates (ICH‑GCP, EU regulations, national guidance) and assess their impact.
  • - Participate in continuous improvement initiatives to strengthen the quality management system.
  • - Maintain accurate and compliant documentation according to QA standards.

Requirements

  • **About You:**
  • **Experience:** Previous experience or strong understanding of **GCP Quality Assurance** in a clinical research environment (pharma, CRO, biotech) is essential.
  • **Skills:**
  • - Solid knowledge of ICH‑GCP, EU CTR, and applicable regulatory frameworks.
  • - Experience in audit conduct (site, vendor, internal) and CAPA management.
  • - Ability to analyze compliance risks and propose pragmatic, process‑oriented solutions.
  • - Strong communication and interpersonal skills to support and guide operational teams.
  • **Education:** Bachelor’s degree in life sciences, pharmacy, or a related scientific field (or equivalent).
  • **Languages:** Fluent in **French and English** (written and spoken).
Benefits
  • **Why Join Us?**
  • At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
  • Here’s what makes us unique.
  • We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s **leading mid-size CRO **with the **best employee experience**. Our **one-stop provider service model **offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
  • **Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GCP Quality Assuranceaudit conductCAPA managementrisk assessmentsSOP developmentquality documentationcompliance analysisprocess-oriented solutionsregulatory inspectionscontinuous improvement
Soft Skills
strong communicationinterpersonal skillstrainingquality guidancesupporting teamsanalytical skillsproblem-solving